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Clinical trial

Feasibility Studies to Investigate the Role of Ursodeoxycholic Acid in the Prevention of Recurrence of C. Difficile Infection

ID
Name
17GA025
Description
The primary objective of the study is to assess tolerability and adherence to treatment with ursodeoxycholic acid
Trial arms
Trial start
2019-05-08
Estimated PCD
2023-12-31
Trial end
2023-12-31
Status
Terminated
Treatment
Ursodeoxycholic acid
Oral
Arms:
Ursodeoxycholic acid
Size
6
Primary endpoint
To assess tolerability to oral ursodeoxycholic acid
6 weeks
Eligibility criteria
Inclusion Criteria: * Completion of a course of antibiotic treatment for C. difficile infection within the previous 7 days Exclusion Criteria: * • Pregnant or Breast-feeding * Gall bladder inflammation * Frequent episodes of biliary colic * Occlusion of the common bile duct or cystic duct * Active small intestinal inflammation * Previous resection of distal small intestine * Treatment with bile salt binding agents, ciclosporin or ciprofloxacin * Diarrhoea (from any cause) at study initiation * hypersensitivity to bile acids or any excipient of the formulation * Life expectancy less than 6 months
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}
Updated at
2024-04-09

1 organization

1 product

1 indication

Organization
Nottingham University Hospitals NHS Trust
Product
Ursodeoxycholic acid
Indication
Clostridioides difficile infection